The present invention is directed to lactose and more particularly toward a lactase enzyme replacement capsule and a method of making the same.
Dairy foods are an important source of protein, riboflavin, and calcium for populations of the United States and Europe, and many people of those countries have a dairy disorder. Acquired lactase deficiency is the most common disorder of complex carbohydrate absorption in all populations. Up to seventy percent of the world's population has this disorder, resulting in gastrointestinal symptoms of excessive gas production, abdominal pain, bloating, and diarrhea after consumption of lactose and the by-products of lactose containing foods, e.g., milk, cheese, cakes, eggs, veal, and yogurt.
All mammals normally have a high level of lactase activity in the lining of the upper intestinal tract because they depend on lactose as the primary carbohydrate in their diet. However, lactase enzyme deficiency occurs naturally with age and genetically, or is secondary to disease states, such as inflammatory bowel disease.
Lactase enzyme replacement products, to date, have generally been useful as a replacement of the deficient enzyme for a short period of time prior to a meal or snack. Since this naturally occurring enzyme is required for digestion of most solid and liquid foods, its use is required by the individual during most periods of eating or snacking, to prevent the symptoms stated above. Failure to take the enzyme replacement products prior to or during a meal by people who experience lactase deficiency, results in poor absorption of the lactose which is then degraded by bacteria to lactic acid, short chain fatty acids and hydrogen gas. This, in conjunction with osmotic pressure created by the lactose, results in diarrhea, pain, gas, and bloating.
Lactose-hydrolyzing lactase enzymes are also known to be produced by various yeasts, bacteria, and fungi. Among the organisms useful in hydrolyzing lactose are Saccharomyces fragilis, Torula cremoris, Lactobacillus bulgaricus, Aspergillus oryzae, Aspergillus flavus, and Aspergillus niger. These organisms are cultured and used to prepare lactase enzyme preparations for lactase replacement products.
A few of the currently available lactase replacement products include, for example, LACTAID brand lactase available from Johnson & Johnson; DAIRY EASE available from Sterling Winthrop, a division of the Eastman Kodak Company; and LACTAID drops also available from Johnson & Johnson. LACTAID tablets utilize lactase of beta-D-galactosidase from the yeast Aspergillus oryzae. LACTAID drops utilize beta-D-galactosidase derived from Kluyveromyces lactis yeast. DAIRY EASE is available in caplets and drops. The caplets utilize lactase of beta-D-galactosidase from the yeast Aspergillus oryzae and the drops utilize beta-D-galactosidase derived from Kluyveromyces lactis yeast The lactase enzyme responsible for the degradation of lactose to glucose and galactose is rapidly metabolized after a meal or snack and within sixty minutes of ingestion before a meal is, for practical purposes, non-existent requiring additional dosing prior to the ingestion of a further meal or snack.
Bacid, another form of lactase replacement products available from Ciba, Self-Medication, Inc. in Woodbridge, N.J. are capsules containing not less than 5 million colonies of Lactobacillus acidophillus which produce lactase for the degradation of lactose. Two of such capsules must be taken prior to each meal/snack. The capsules arc exceedingly sensitive at ambient temperatures and if not refrigerated, rapid death of the Lactobacillus cells results with subsequent ineffectiveness of the product.
Problems associated with various lactase enzyme replacement products are discussed, for example, in U.S. Pat. No. 3,718,739 to Cayle which discloses a method of administering an acid-active, acid-stable lactase enzyme preparation for the hydrolysis of lactose in acid media such as gastric fluids of lactase-deficient mammals. The lactase replacement preparation and treatment, however, does not provide a preparation in unit dosage form which has long acting capability nor is it impervious to elevated temperatures and moisture over long periods of time.
Accordingly, there exists a need for a dietary lactase replacement available in capsule and the like unit dosage form, containing Lactobacillus acidophillus or the like cultured strain, which is capable of sustaining activity for an extended period of time, e.g., a minimum of ten hours upon a single ingestion, and which exhibits suitable thermal resistance, thus allowing the lactase deficient user to supplement his/her diet at will with lactose containing food/liquid entities without any undesirable side effects of the same while permitting the storage and shipping of such preparations without loss of activity.